U.S. FDA Conducts Inspection of Lupin’s Dabhasa Facility, Finds No Observations

Lupin Limited, a leading global pharmaceutical company, announced today that the United States Food and Drug Administration (U.S. FDA) has successfully completed a Good Manufacturing Practice (GMP) Inspection of its Active Pharmaceutical Ingredient (API) manufacturing facility situated in Dabhasa, India. The inspection, which took place from April 8 to April 12, 2024, concluded with no observations.

Nilesh Gupta, Managing Director of Lupin, expressed satisfaction with the outcome, stating, “We are pleased to announce the successful completion of the U.S. FDA inspection of our Dabhasa facility. This achievement highlights our steadfast commitment to upholding the highest standards of quality and compliance across all facets of our operations. It reinforces our dedication to delivering top-notch, affordable healthcare solutions for everyone.”

Lupin, headquartered in Mumbai, India, is an innovative pharmaceutical company with a global footprint. It develops and markets a diverse portfolio of branded and generic formulations, biotechnology products, and APIs across more than 100 markets worldwide, including the U.S., India, South Africa, Asia Pacific (APAC), Latin America (LATAM), Europe, and the Middle East.

The company holds a leading position in key therapeutic segments such as cardiovascular, anti-diabetic, and respiratory, and maintains a significant presence in areas including anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health. Lupin ranks as the third-largest pharmaceutical company in the U.S. based on prescriptions filled. In the fiscal year 2023, the company allocated 7.9% of its revenue to research and development initiatives.

Lupin operates 15 manufacturing facilities, 7 research centers, and employs over 20,000 professionals worldwide. It has consistently been recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.

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